Prolozone Therapy for Osteoarthritis of the Knee Study

Comparison of the analgesic efficacy of combined peri-articular hypertonic dextrose prolotherapy, intra-articular Magnesium and Ozone (Dextrose Magnesium Ozone Therapy) with Intra articular Corticosteroid in the management of moderate-severe Osteoarthritis of the Knee: Randomized Double-Blind, Placebo-controlled Trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059765

Enrollment

180

Registered

2023-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hypertonic dextrose, ozone, magnesium: Under real-time ultrasound guidance, a 21-gauge 50 mm needle will be positioned in the supra-patellar recess and 8 ml of 15% dextrose and 500 mg o

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged 40 years and above, who meet the American College of Rheumatology criteria for osteoarthritis (knee pain for most of the days of the previous month and osteophyte (s) at the joint line visible on X ray) 29, are willing to consent and have moderate-severe OAK. Clinical Severity: Patients should have a mean score of 1.5 - 3.5 on WOMAC A sub score30, 31. Radiological Severity of Osteoarthritis of the knee is based on the criteria defined by Kellgren and Lawrence, which grades OAK into 0-4 grades32. This study will be including Grade 3 and Grade 4 Osteoarthritis of the knee

Exclusion criteria

Exclusion criteria: Participants unwilling to provide consent Patients with mild OAK Participants with known history of drug allergy to bupivacaine, corticosteroid or lidocaine Patients on anticoagulant or antiplatelet medication Patients who have had a myocardial infraction in the last 6 months Patients with secondary OAK (gout, RA, Psoriasis) or generalized osteoarthritis Patients who have received intra articular steroids into any joint within 3 months

Design outcomes

Primary

Measure	Time frame
Change from in mean WOMAC A sub score at 24 weeks after third treatment between groupsTimepoint: Change from in mean WOMAC A sub score at 24 weeks after third treatment between groups	—

Secondary

Measure	Time frame
30 seconds sit to stand testTimepoint: Baseline and at 3, 6, 12, 24 weeks after the third treatment;WOMAC Total scoreTimepoint: Baseline and at 3, 6, 12, 24 weeks after the third treatment;Patient Satisfaction with managementTimepoint: 24 weeks after the third treatment;Radiological change in knee joint space (DMO arm only) Timepoint: at 24 weeks after third treatment	—

Countries

India

Contacts

Public ContactDr Niraj Gopinath

Sri Madhusudan Sai Institute of Medical Sciences and Research,

niraj.gopinath@smsimsr.org9036119279

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026